Regulatory
The designation will provide for an expedited pathway for regulatory review of the preventative medication, which could come later this year.
The U.S. Food and Drug Administration issued a Complete Response Letter to Merck and Eisai over their Lenvima and Keytruda combination for first-line treatment of unresectable hepatocellular carcinoma (HCC).
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 10, 2020.
The submission was completed with ongoing collaboration with the FDA and include data from the Phase III EMERGE and ENGAGE trials, as well as the Phase Ib PRIME study. Biogen has also requested Priority Review.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 8, 2020.
Cellectis, based in Paris and New York, announced that the U.S. Food and Drug Administration (FDA) had placed a clinical hold on its MELANI-01 trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
It’s a relatively slow month ahead for July in terms of PDUFA dates for the U.S. FDA. However, there are several dates pending throughout the month. Here’s a look at three for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
Meet with regulatory affairs professionals early and often. That’s the message from Neelu Gibson, VP, regulatory affairs, at BD, speaking at Biocom’s June virtual meeting, “Regulatory Affairs…Engagement Do’s & Don’ts.”
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